A key organisation for companies aiming to sell within the National Health Service
NICE’s role is to improve outcomes for people using the NHS and other public health and social care services. They do this by:
- Producing evidence based guidance and advice for health, public health and social care practitioners
- Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services
- Providing a range of informational services for commissioners, practitioners and managers across the spectrum of health and social care
For organisations wishing to seek advice from NICE on their products (including drugs, devices, diagnostics), there are several services available. Contact NICE via their website for more information.
This is the most detailed service provided by NICE Scientific Advice and is intended to explore trial design and methodological issues in health technology assessment (HTA).
Advice is given to ensure that development plans can produce relevant evidence for a health technology assessment or wider discussions with commissioners/payers. An initial submission of the company’s proposals and questions in the form of a briefing document is expected. It includes a face-to-face meeting with NICE SA and an independent panel of experts individually selected based on the issues involved.
A detailed advice report answering the company’s questions and containing NICE’s formal advice is the final deliverable, with the company allowed to seek clarification of the issues contained therein. This service is recommended particularly for large or complex clinical development or economic modelling plans but can be utilised by any company wishing to seek detailed feedback on their proposals.
The process takes 18-20 weeks, and there is a fee of £38,000-£50,000.
Parallel advice (EMA)
This service is aimed at pharmaceutical companies who wish to seek advice on HTA issues in parallel with European Medicines Agency (EMA) regulatory advice on trial design.
Just one briefing document is prepared by the company that incorporates HTA questions, regulatory questions and questions relevant to both. The service includes feedback on a pre-validated briefing book (if requested), a list of key issues produced by the EMA and HTA bodies, and a face-to-face meeting in London with representatives from the EMA and European national HTA bodies selected by the company.
An advice letter from NICE SA responding to the questions posed by the company follows the meeting. This service is less suited to an in-depth discussion of technical issues related to HTA but results in advice from HTA bodies in multiple national jurisdictions, which try to harmonise their advice to the largest extent possible. The process is managed by the EMA and carries a cost of £15,500 for NICE to participate.
Parallel advice (MHRA)
This service is similar to the standard advice process, except that it is aimed at pharmaceutical companies who wish to seek advice on regulatory and HTA issues in parallel.
One briefing document relevant to advice from both regulatory and HTA agencies will need to be submitted. The service includes a face-to-face meeting with NICE and the MHRA and separate advice reports from both bodies. This service allows detailed advice to be sought on regulatory issues, trial design, and HTA and methodological issues.
This service is designed exclusively for Small and Medium Enterprises (SMEs) and developers of medical devices or diagnostics.
It includes advice at the stage of developing the briefing document to help with the understanding of the needs of NICE evaluation as well as information required by NICE SA.
The service does not include a face-to-face meeting, but companies will still receive a written advice letter responding to questions. Discussion on development of the briefing document and clarification of the advice letter take place by teleconference between NICE SA and the company.
Pharmaceutical SMEs have an option to seek parallel light advice from NICE and the MHRA. This is similar to the process described above except that the face-to-face meeting is shorter, excluding the NICE-selected panel of experts.
MedTech companies have an option to seek additional advice from NICE’s Adoption and Impact Programme, who provide practical advice on the adoption of a particular technology into the NHS. Light advice is currently priced at £15,000.